BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAGNER SL REVISION HIP STEM, UNCEMENTED, 16/265, TAPER 12/14

    MDR report key: 7057049 · Received November 23, 2017

    Report

    Report Number
    0009613350-2017-01621
    Event Type
    Malfunction
    Date Received
    November 23, 2017
    Date of Event
    October 5, 2017
    Report Date
    June 20, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    P043356
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D11: CONCOMITANT MEDICAL PRODUCT: WAGNER SL REVISION, AWL, 16, REF#: 01.00102.616, LOT#: 2849829. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE SURGEON ADDRESSED A PERIPROSTHETIC HIP FRACTURE, PLACING TWO CABLES TO REUNITE THE FEMUR. HE REAMED AGGRESSIVELY BY HAND. THE PROVISIONAL STEM FIT WELL AFTER MODERATE IMPACTION. WHEN THE ACTUAL STEM WAS PLACED WITH SIMILAR FORCE IT ENDED SEVERAL CENTIMETERS DEEPER INTO THE FEMORAL CANAL. IT IS ALSO REPORTED ADDITIONALLY THAT THE AWL USED FOR THE SURGERY WAS SIZE 16 (REF: 0100109016 LOT: 14013472). REVIEW OF RECEIVED DATA: ONE PHOTO OF THE STEM WAS RECEIVED, WHICH DO NOT CONVEY ANY VALUABLE INFORMATION FOR THE INVESTIGATION. DEVICES ANALYSIS: VISUAL EXAMINATION: THE WAGNER SL REVISION STEM, 16/265 (REF: 0100102616 LOT: 2849829) WAS RECEIVED FOR THE INVESTIGATION OF THE COMPLAINT.SLIGHT SCRATCHES AND WORN AREA AT THE SHOULDER OF THE PROSTHESIS ARE VISIBLE. THEY ARE SUPPOSED TO BE DUE TO PLACEMENT OF THE IMPLANT IN THE BONE WHILE BEING SCREWED ONTO THE THREADED HOLE. RESPECTIVE CHACARATICTICS NO 28, 30 AND 32 BEING THE DIMENSIONS OF THE STEM AT DIFFERENT HEIGHTS, SPECIFICALLY AT THE B-B, C-C AND E-E SECTIONS, WERE MEASURED ACCORDING TO THE TECHNICAL DRAWING AND IT IS CONFIRMED THAT ALL THE MEASURED VALUES CORRESPONDS TO THE VALUES SPECIFIED IN THE DRAWING, NAMELY 17MM, 16MM AND 12.37MM. THEREFORE , THE RIGHT SIZE OF THE STEM CAN BE CONFIRMED. REVIEW OF PRODUCT DOCUMENTATION: INSPECTION PLAN WAGNER CONE PROSTHESIS: CHARACTERISTICS 25, 28, 30, 31 AND 32 WERE MEASURED WITH 3D MACHINE WITH 100% VISUALLY/QUALITATIVELY AND QUANTITATIVELY. CHARACTERISTIC 25 "DIMENSION ( C 0.3/0)" MEASURED WITH CMM WITH 100% SCOPE. CHARACTERISTIC 28 "DIMENSION ( A 0.2/-0.1)" MEASURED WITH CMM WITH 100% SCOPE. CHARACTERISTIC 30 "DIMENSION ( B 0.2/-0.1)" MEASURED WITH CMM WITH 100% SCOPE. CHARACTERISTIC 31 "DIMENSION ( K 0.3/0)" MEASURED WITH CMM WITH 100% SCOPE. CHARACTERISTIC 32 "DIMENSION ( J 0.2/-0.1)" MEASURED WITH CMM WITH 100% SCOPE. CORRECT IMPLANTATION TECHNIQUE OF THE FEMORAL STEM IS INDICATED IN THE SURGICAL TECHNIQUE FOR WAGNER SL REVISION STEM . ROOT CAUSE ANALYSIS: ASSUMING THAT THE CORRECT SIZES OF DISTAL TRIAL (SIZE 16) WAS USED, THE TRIAL STEM AND THE IMPLANT HAVE THE EXACT SAME DIMENSIONS IN THE ANCHORING AREA. HOWEVER, FOR A BETTER FINAL FIT, THE IMPLANT HAS TWICE AS MANY RIPS. THE CONICAL REAMER HAS THE SAME CONTOUR BUT IS SLIGHTLY THINNER THAN TRIAL STEM AND FINAL IMPLANT (INCLUDING THE RIPS). THIS MAKES IT POSSIBLE FOR THE RIP TO BE CARVED INTO THE CORTICAL BONE AND THEREBY REACH SUFFICIENT PRESS FIT. THE STEM DIAMETER DOWNSIZES TOWARDS DISTAL WITH A CONE ANGLE OF 2° IN ORDER TO PREVENT SUBSIDENCE. IT IS HIGHLY POSSIBLE THAT THE SURGEON WAS UNFAMILIAR WITH IMPLANTATION TECHNIQUE. CONCLUSION SUMMARY: ACCORDING TO THE EVENT THE STEM SUBSIDED SEVERAL CENTIMETER DEEPER THAN EXPECTED. THE STEM WAS RETURNED FOR THE INVESTIGATION. THE AWL USED WAS REPORTED, WHEREAS THE PROVISIONAL STEM USED IS NOT KNOWN. THE RELEVANT DIMENSIONS OF THE FEMORAL STEM WERE CHECKED DURING FINAL INSPECTION WITH A 100% SCOPE ACCORDING TO THE INSPECTION PLAN. MANUFACTURING HISTORY RECORDS OF THE STEM SHOWED THAT RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. MEASUREMENT OF THE STEM'S RELEVANT DIMENSIONS CONFIRM THAT THE SIZE OF THE STEM IS ACCORDING TO THE DRAWINGS. VISUAL EXAMINATION OF THE STEM DID NOT SHOW ANY PRODUCT PROBLEMS EXCEPT THE SLIGHT SCRATCHES HAPPENED DURING THE PLACEMENT OF THE STEM IN OP. KNOWING THAT THE CORRECT SIZE OF THE AWL WAS USED, IT IS POSSIBLE THAT THE SURGEON USED THE AWL EXCESSIVELY AND THEN IT LED TO A BIGGER CAVITY RESULTING IN A NEED OF BIGGER SIZE OF STEM. HOWEVER, THERE IS NO EVIDENCE TO CONFIRM. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A WAGNER SL REVISION HIP STEM, UNCEMENTED, 16/265, TAPER 12/14 ON THE LEFT SIDE ON (B)(6) 2017. THE PROVISIONAL STEM FIT WELL AFTER MODERATE IMPACTION. WHEN THE ACTUAL WAGNER SL STEM WAS PLACED WITH SIMILAR FORCE IT ENDED SEVERAL CENTIMETERS DEEPER INTO THE FEMORAL CANAL. IT WAS ALSO REPORTED THAT THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835908 WAGNER SL REVISION HIP STEM, UNCEMENTED, 16/265, TAPER 12/14 WAGNER SL REVISION STEM LATERAL LZO ZIMMER GMBH N/A 2849829

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE